Senior Manufacturing Process Technician
BioSpace · Thousand Oaks, CA · 1 mo ago
ManagementFull-time
About the role
At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. As a Senior Manufacturing Process Technician, you will play a hands-on role in the safe, compliant, and effective execution of solid oral dosage manufacturing operations in a GMP-regulated environment. You will independently perform manufacturing activities including equipment setup and operation, process monitoring, cleaning and equipment turnaround, troubleshooting, and GMP documentation, with particular emphasis on granulation, blending, and tablet compression. This role requires ownership of manufacturing execution, recognition and response to abnormal conditions, and contribution to safe, reliable, and efficient production.
Responsibilities
- Independently execute manufacturing operations in accordance with approved batch records, standard operating procedures (SOPs), GMP requirements, and established safety practices.
- Set up, operate, monitor, and clean manufacturing equipment supporting solid oral dosage manufacturing, with particular emphasis on granulation, blending, and tablet compression operations.
- Execute and support all phases of manufacturing activities, including material preparation and handling, dispensing, equipment assembly, processing, in-process monitoring, equipment breakdown, cleaning, and preparation for subsequent operations.
- Perform routine troubleshooting of process and equipment issues and effectively communicate and escalate conditions requiring additional technical or leadership support.
- Execute cleaning and sanitization of manufacturing equipment and production areas as an integral part of manufacturing operations and equipment ownership.
- Maintain manufacturing areas in a clean, organized, safe, and inspection-ready condition.
- Complete batch records, equipment logs, forms, and other GMP documentation accurately, contemporaneously, and in accordance with Good Documentation Practices.
- Actively identify opportunities to improve safety, quality, equipment reliability, manufacturing efficiency, and workplace organization.
- Follow all applicable GMP, safety, quality, and compliance requirements.
Requirements
- High school/GED plus 2 years of manufacturing, production, operations, maintenance, warehousing, logistics, or another hands-on technical work experience, or
- Associate degree plus 6 months of manufacturing, production, operations, maintenance, warehousing, logistics, or another hands-on technical work experience, or
- Bachelor’s degree.
Qualifications
- Hands-on experience in a pharmaceutical manufacturing environment.
- Experience with solid oral dosage manufacturing processes, particularly granulation, blending, and/or tablet compression.
- Experience setting up, operating, monitoring, troubleshooting, disassembling, and cleaning manufacturing equipment.
- Understanding of cGMP requirements, Good Documentation Practices, and manufacturing quality systems.
- Experience executing equipment changeovers, line clearances, cleaning, sanitization, or manufacturing area turnaround activities.
- Demonstrated reliability, accountability, initiative, and commitment to continuous improvement.
- Strong communication, teamwork, situational awareness, and problem-solving skills.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.